Minimally invasive surgery is a revolutionary new technique that replaces standard invasive surgical operations requiring large incisions with operations utilizing very small incisions. In this technique, access to the surgical field is made through very small incisions (generally 5-18 mm in diameter) via a surgical trocar. Tubes are then inserted through the incision to permit the further introduction of miniaturized instruments that can be manipulated by a surgeon while viewing the surgical field on a television monitor. This technology affords the patient considerably less pain and disfigurement, and a much faster recovery. The rapid return of the patient to productive activity further reduces the ultimate cost of the surgery.
Although trocars are widely used to puncture the abdominal wall as a first step in minimally invasive surgical techniques, such use creates several serious clinical problems. The very small size of the incision and the somewhat awkward access to the interior facies of the tissues surrounding the incision make closure of the incision problematic and time consuming. For example, one method requires the introduction of a pre-threaded suture needle approximately 3-5 mm from the edge of the original trocar incision. The surgeon views the needle via a laparoscope as it pierces the abdominal wall. The surgeon then grasps the ligature in the pre-threaded needle with a forceps, eventually secures it, passes it to an empty needle that has been introduced on the opposite side of the surgical defect, and withdraws the empty needle up through the other side of the incision, through the abdominal wall, and ties off the suture. The knot is generally tied under the skin to avoid residual external scarring.
Because the surgeon cannot directly visualize the exact position of the needle until after it has passed completely through the abdominal wall, several insertions may be required in order to place the needle at an ideal and proper distance from the trocar incision. The distance from the needle location to the original incision is critical in that the needle must be far enough from the trocar incision to secure an optimal amount of abdominal wall tissue. If the needle distance from the incision is too small, an insufficient amount of tissue will be secured with a consequent risk of inadequate closure of the surgical defect. This may result in subsequent herniation of the omentum or bowel. However, if needle distance from the point of the original trocar incision is too great, incision closure will result in excessive tissue being grasped, and the patient will be left with an unsightly "knot" of tissue.
Aside from attendant awkwardness and the problems resulting therefrom, this method is time-consuming, serendipitous, and produces only marginal closure integrity. Further, this method affords a very significant risk to the patient in that the more or less blind nature of needle insertion, placement and removal may result in laceration of additional blood vessels, thereby exacerbating blood loss and increasing operation time until the damaged blood vessels can be secured and controlled.
Another common technique for closing a trocar incision comprises the reapproximation of the fascia and subcutaneous fat by means of a small needle introduced through the trocar skin incision from outside the body at the termination of the procedure. The difficulty with this technique is that the edges of the fascia are not visualized, with the result that tying the ligature may or may not effectively reapproximate the edges of the fascia. Certainly the peritoneal defect is not effectively closed by this approach because the suture is not placed deeply enough. Further, the blood vessels that are prone to be injured (and therefore bleed) by insertion of the trocars tend to be located immediately external to the peritoneal layer. Because the suture ligature is more or less superficial, suturing of the incision is generally inadequate to ligate these deeper blood vessels.
Often times, closure of the trocar incision is nothing more than skin deep, the deeper layers of the fascia remaining free. Failure to make complete closure of the incision entails a significant risk of delayed bleeding (occurring after the abdomen is deflated and the tamponading effect of the inflated abdomen ceases), or the possibility of herniation of either omentum or bowel into the subcutaneous opening.
Occasionally, the peritoneal defect may be approximated by a traditional, curved-needle suture ligature that is placed from within the abdominal cavity under direct vision. The knot is then tied either by means of an intra-corporeal or extra-corporeal knot-tying technique. This approach is rarely used because it is cumbersome, requires a high level of skill, and is still not optimal as it ensures only that the peritoneum is closed, closure of the more exterior fascia being purely speculative.
In view of the foregoing there is a clear need for a suturing device and method of incision closure that is accurate and reliable, and that does not require an excessive amount of time to complete.
There is also a need for a suturing device that positions the needle in a desired location without excessive risk of injury to blood-carrying vessels.
There also exists a need for a surgical device and method that can be utilized by a surgeons having various skill levels.
A further need is for a suturing device that allows the surgeon to place the suturing needles precisely at a desired distance from and at a desired angular orientation relative to the original trocar incision.